COOLTOUCH, MODEL CT3S by NEW STAR LASERS, INC.

The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, and/or the handpiece.

AI/ML Overview

The provided text is a 510(k) summary for the CoolTouch Corporation Model CT3S Nd:YAG Laser System. It focuses on regulatory approval and device specifications rather than detailed clinical study data with specific acceptance criteria and performance metrics typically found in clinical trial reports.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment cannot be fully answered from the provided document. The document explicitly states "Non-clinical Performance Data: None" and for clinical data refers to "previous related 510(k) submissions."

Acceptance Criteria and Study Information for CoolTouch CT3S Nd:YAG Laser System

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify quantitative acceptance criteria or detailed performance metrics from a specific study for the CoolTouch CT3S Nd:YAG Laser System. The clinical performance section states:

"Clinical trials also produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities. See previous related 510(k) submissions for clinical results."

This statement confirms that clinical trials were conducted and supported effectiveness, but the specific performance results or acceptance criteria are not included in this document. The 510(k) process primarily demonstrates substantial equivalence to a predicate device, which may not require new, full-scale clinical trials if sufficient prior data or a clear technological equivalence exists.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given 510(k) summary. The document refers to "previous related 510(k) submissions for clinical results," implying the data was drawn from prior studies, but details about sample size, country of origin, or retrospective/prospective nature are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the given 510(k) summary. Given the nature of a laser system for surgical and dermatological applications, ground truth would likely involve clinical assessment by qualified medical professionals (e.g., dermatologists, vascular surgeons), but specifics are not mentioned here.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided in the given 510(k) summary. This type of study is more common for diagnostic AI systems evaluating image interpretation, which doesn't directly apply to a laser surgical device in the same way.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided in the given 510(k) summary. The CoolTouch Nd:YAG Laser System is a physical medical device, not an algorithm, and its operation inherently involves a human operator (a clinician). Therefore, a "standalone algorithm only" performance study is not relevant to this device.

7. The Type of Ground Truth Used

The document refers to "clinical trials" demonstrating effectiveness, particularly for treating reflux of the greater saphenous vein. This strongly suggests that the ground truth would have been based on clinical outcomes data (e.g., successful vein closure, reduction in varicose veins, improvement in cosmetic appearance for skin treatments) as assessed by clinicians. However, the specific methodology for establishing this ground truth (e.g., objective measurements, physician assessment scales, imaging confirmation) is not detailed in this summary.

8. The Sample Size for the Training Set

This information is not provided in the given 510(k) summary. As this is not an AI/machine learning device, the concept of a "training set" in the context of data for model development does not apply in the typical sense. Data from previous clinical trials would inform the device's design and demonstrate its safety and effectiveness, but it wouldn't be a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided in the given 510(k) summary, as it pertains to an AI/machine learning context which does not apply to this device. Clinical data from prior studies (as referenced) would have established their respective ground truths based on clinical assessments and outcomes.

Summary

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CoolTouch Corporation Model CT3S Nd:YAG Laser System 510(k) Premarket Notification 510(k) SUMMARY

人 043046

Submitter:	CoolTouch Corporation
Address:	9085 Foothills BoulevardRoseville, CA 95747
Contact Person:	Donald V. JohnsonVice-President of Operations
Telephone:	(916) 677-1912
Facsimile:	(916) 677-1901
Date Prepared:
Device Trade Name:	CoolTouch Corporation Model CT3S Nd:YAG LaserSystem
Common Name:	Nd: YAG Surgical Laser
Classification Name:	Laser Surgical Instrument.21 C.F.R. § 878.4810
Legally Marketed Predicate Device:	CoolTouch Corporation Model NS-160, CTEV.
Description of the CoolTouchNd:YAG Laser Systems:	The CoolTouch Nd:YAG Laser Systems are Nd:YAGlasers producing laser emission at 1320 nm. The lasersconsist of three interconnected sections: The cabinet,which houses the power supply, cooling system,microcontroller and the laser, the fiber optic, and/or thehandpiece.
Intended use of CoolTouchNd:YAG Laser Systems:	The intended use of the CoolTouch CT3S Nd:YAGLaser System is:a) for use in dermatology for incision, excision, ablationand vaporization with hemostasis of soft tissue,b) for treatment of fine lines and wrinkles,c) for treatment of back acne and atrophic acne scars,d) for treatment of reflux of the greater saphenous veinassociated with varicose veins and varicosities.
Nonclinical Performance Data:	None
Clinical Performance Data:	Clinical trials also produced results that indicated thatthe CoolTouch Nd:YAG Laser Systems are effective inthe treatment of reflux of the greater saphenous veinassociated with varicose veins and varicosities. Seeprevious related 510(k) submissions for clinical results.
Conclusion:	The CoolTouch CT3S Nd:YAG Laser System isindicated:a) for use in dermatology for incision, excision, ablationand vaporization with hemostasis of soft tissue,b) for the treatment of fine lines and wrinkles,c) for treatment of back acne and atrophic acne scars,d) for treatment of reflux of the greater saphenous veinassociated with varicose veins and varicosities.
Additional Information:	None requested at this time

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping lines, which represent the department's mission to protect the health of all Americans and provide essential human services.

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald V. Johnson Vice President of Operations CoolTouch Corporation 9085 Foothills Boulevard Roseville, California 95747

Re: K043046

Trade/Device Name: CoolTouch CT3S Nd:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 21, 2005 Received: January 24, 2005

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererors, mans of the Act include requirements for annual registration, listing of general controls profice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rryour device is elassified (tools. Existing major regulations affecting your device can may be subject to suen adaterial evenlations. Title 21, Parts 800 to 898. In addition, FDA may be round in the over ments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean ITCase oc advised that I DTC issuantes syour device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must of ally it catal statutes und regalabents, including, but not limited to: registration and listing (2 h Comply with an the Hot 31equirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Donald V. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your and inding of substantial equivalence of your device to a legally premaince notificated in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please ir you dome office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golferal micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number: __ K 04304b____________________________________________________________________________________________________________________________________________________

Device Name: CoolTouch CT3S Nd:YAG Laser System

Indications for Use:

The CoolTouch CT3S Nd:YAG Laser System is indicated:

a) for use in dermatology for incision, excision, ablation and vaporization with

hemostasis of soft tissue,

b) for use in the treatment of fine lines and wrinkles,

c) for treatment of back acne and atrophic acne scars,

d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Pror (Division Sign-Off) Division of General, Restorative, and Neurological Devices KO 4 38ver-the-Counter Use_ OR Prescription Use 510(k) Number 1 CFR 801.109)

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.